A Prospective, Multicenter, Randomized, Evaluator-Blinded, Confirmatory Study to Evaluate the Efficacy and Safety of LEXURE for Improving Language Function in Patients With Post-Stroke Aphasia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Nunaps Inc
- 入组人数
- 116
- 试验地点
- 12
- 主要终点
- Change in K-WAB/PK-WAB-R AQ
研究概览
简要总结
This study evaluates the efficacy of digital language rehabilitation using LEXURE for the treatment of post-stroke aphasia. Half of participants will receive structured language training using the LEXURE application, while the other half will receive workbook-based language training as an active comparator.
详细描述
This study is a prospective, multicenter, randomized, evaluator-blinded confirmatory clinical trial designed to evaluate the efficacy and safety of LEXURE, a digital therapeutic for language in patients with post-stroke aphasia.
Eligible participants who provide informed consent will undergo screening and be randomized in a 1:1 ratio to either the LEXURE group or the control group.
LEXURE Group:
Participants assigned to the LEXURE group will receive structured digital language training using the LEXURE application. The training consists of multiple language tasks and will be performed for approximately 30 minutes per session, 5 times per week, for 10 weeks.
Control Group:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosed with hemorrhagic or ischemic stroke
- •At least 3 months have elapsed since stroke onset
- •History of aphasia resulting from stroke
- •Aphasia Quotient (AQ) score between 26 and 90 (inclusive) on the Korean version of the Western Aphasia Battery (K-WAB) or the Paradise Korean version of the Western Aphasia Battery-Revised (PK-WAB-R)
- •Adults aged 19 years or older
- •Native Korean speakers
- •Able to use the investigational device or perform workbook-based training without difficulty
- •Willing to participate voluntarily and provide written informed consent
排除标准
- •Diagnosed with language impairment due to causes other than stroke (e.g., traumatic brain injury, brain tumor, or neurodegenerative disease)
- •History of language impairment due to developmental disorders
- •Currently receiving speech-language therapy or participating in another clinical trial related to language function
- •Currently receiving medication for severe psychiatric disorders (e.g., bipolar disorder, major depressive disorder, schizophrenia, alcohol dependence, or substance abuse)
- •Illiterate individuals
- •Individuals deemed unsuitable for participation in this study by the investigator
- •Severe cognitive impairment that would interfere with understanding or performing the study interventions
研究组 & 干预措施
Workbook
Participants assigned to this arm will receive a language therapy workbook and perform structured language exercises as a control intervention.
干预措施: Workbook (Behavioral)
LEXURE
Participants assigned to this arm will receive language training intervention using the LEXURE digital therapeutic (DTx) software.
干预措施: LEXURE (Device)
结局指标
主要结局
Change in K-WAB/PK-WAB-R AQ
时间窗: Baseline to Week 10
change in Aphasia Quotient (AQ) score from baseline to Week 10, measured using the K-WAB/PK-WAB-R. The AQ score reflects overall language function, Assessments will be conducted by an independent, evaluator-blinded assessor.
次要结局
- Change in K-WAB/PK-WAB-R Spontaneous Speech Score(Baseline to Week 10)
- Change in K-WAB/PK-WAB-R Auditory Comprehension Score(Baseline to Week 10)
- Change in K-WAB/PK-WAB-R Repetition Score(Baseline to Week 10)
- Change in K-WAB/PK-WAB-R Naming and Word Finding Score(Baseline to Week 10)
- Mean change in K-WAB/PK-WAB-R Aphasia Quotient (AQ) in the study group(Baseline to Week 10)